Below is a raw (and likely hideous) rendition of the
original report.
(PDF)

United States General Accounting Office
GAO Report to the Chairman, Committee on
Health, Education, Labor and Pensions,
U.S. Senate
December 1999
VACCINE INJURY
COMPENSATION
Program Challenged to
Settle Claims Quickly
and Easily
GAO/HEHS-00-8
United States
GAO General Accounting Office
Washington, D.C. 20548
Health, Education, and
Human Services Division
B-281968
December 22, 1999
The Honorable James M. Jeffords
Chairman, Committee on Health,
Education, Labor and Pensions
United States Senate
Dear Mr. Chairman:
Infectious diseases are responsible for nearly half of all deaths worldwide
of people under the age of 44. In the United States, vaccinating children
against such diseases is considered to be one of the most effective public
health initiatives ever undertaken. Since vaccination programs began, the
number of people contracting vaccine-preventable diseases in the United
States has been reduced by more than 95 percent. In some instances,
however, a vaccine can have severe side effects, including death or
disabling conditions requiring lifetime medical care. In the 1980s, lawsuits
stemming from such incidents threatened to affect the availability and cost
of vaccines as well as the development of new ones.
To address this issue, the Congress, beginning in 1986, created a different
approach for compensating people injured by certain vaccines routinely
provided in childhood. Instead of suing vaccine manufacturers and
vaccine administrators, people—including adults—who believe they have
been injured by these vaccines must first file a claim under the Vaccine
Injury Compensation Program (VICP).1 VICP contains a vaccine injury table,
which is designed to minimize difficulties petitioners have in proving that
their injury resulted from a vaccine. The injuries listed on this table are
presumed to have been caused by certain vaccines, unless the government
can prove otherwise. By contrast, in a lawsuit filed under the civil tort
system, the injured party bears the burden of proving that the vaccine
caused injury.
Administered by the Department of Health and Human Services (HHS), the
program pays claims from a trust fund supported by an excise tax on each
dose of vaccine that is covered by the program.2 As of February 1999, 5,355
1
When VICP became effective in October 1988, it covered vaccines required for immunizing children
against seven infectious childhood diseases: diphtheria, pertussis (whooping cough), tetanus, polio,
measles, mumps, and rubella (German measles). Vaccines against hepatitis B, hemophilus influenzae
type b (Hib), and varicella (chicken pox) were added to the program in August 1997; and a vaccine
against rotavirus was added, effective October 1998.
2
Claims arising from vaccinations administered prior to October 1, 1988, are paid from general fund
appropriations.
Page 1 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
claims had been filed under VICP and close to $1 billion had been awarded
since October 1988, when the program became effective. The majority of
claims filed and compensation paid have been for neurological injuries
associated with the DTP (diphtheria, tetanus, and pertussis) vaccine.
Although VICP was created to provide compensation “quickly, easily, with
certainty and generosity,”3 there is debate surrounding how well the
program meets this purpose. Some contend that the claims process takes
too long and that recent changes to the program’s vaccine injury table
make compensation too difficult to obtain. Another concern is the VICP
trust fund, which had a balance of $1.3 billion at the end of fiscal year 1998
and has been collecting much more than it pays out in claims. To help with
congressional oversight of the management and financing of the program,
you asked us to determine
• how long it takes to process a claim through VICP;
• the extent that recent changes to the program’s injury table have made it
easier or more difficult for petitioners to obtain compensation for
vaccine-related injuries; and
• why the trust fund continues to grow, and what budgetary effect proposed
options for addressing the growing trust fund balance would have.
Our work included analyses of claims data from HHS’ VICP database from
the inception of the program to February 1999. We supplemented our
analyses with interviews and information from the federal agencies
responsible for the VICP claims process and financial accounting of the VICP
trust fund, petitioner advocates, members of the scientific community, and
a pediatric physician professional organization. (See app. I for more on our
scope and methodology.) We conducted our work from January through
November 1999 in accordance with generally accepted government
auditing standards.
Overall, while the program appears to provide an easier process for
Results in Brief obtaining compensation than the traditional civil tort system, the process
has not been as quick or as easy as expected. Processing most VICP claims
takes more than 2 years. The Congress expected the program to process
claims in 1 year or less, but only about 14 percent of claims met this
expectation. In 1988 and 1989, the program received about 200 claims and
processed nearly all of them within 2 years. But in 1990, when a filing
3
Report of the House Committee on Energy and Commerce accompanying the legislation establishing
VICP, H.R. Rep. No. 99-908, p. 3 (1986).
Page 2 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
deadline neared for injury claims relating to vaccinations received before
October 1988, the number of claims filed jumped to over 3,200. This influx
created an immediate and large backlog of claims, which HHS is still
working to resolve. Another factor significantly increasing processing
times is that as the program received additional funding for staff and
experts to defend claims, the government increasingly challenged claims
in which the cause of injury was in doubt. As a result, petitioners needed
more information and time to prepare cases, which resulted in processing
times that were much longer than envisioned when the program began.
HHS’ recent changes to the vaccine injury table will make the process
easier for some people to obtain compensation, but will make it more
difficult for a larger number to do so. This is because far more claims have
historically been associated with injuries HHS removed from the table than
with injuries HHS added to it. For example, about half of the awards made
since the program’s inception have been for neurological injuries that HHS
later removed from the table in 1995 and 1997. Removing these injuries
shifts the burden of proof to the petitioner, making it more difficult to
qualify for compensation under VICP. HHS based its decisions to add or
remove table injuries on various factors but did not have a clear and
transparent methodology to demonstrate that these factors were
consistently applied for each injury table change. Without such
transparency, changes that make compensation more difficult for
petitioners may continue to be questioned by some, regardless of their
merit. We are making a recommendation to HHS to develop and apply a
consistent methodology for its decisionmaking process for making
changes to the vaccine injury table.
The VICP trust fund has grown to $1.3 billion, primarily because the income
from vaccine excise taxes has been higher than payments for claims and
associated administrative costs and interest has been accruing on the fund
balance. The excess tax revenue—$948 million, as of 1998—has been
loaned to the Treasury and used for other federal programs and activities.
Vaccine manufacturers, federal agencies, and petitioner advocates have
expressed concerns about the rising balance and have proposed options to
decrease the vaccine excise tax or increase trust fund spending.
Exercising these options, however, would have implications for the overall
federal budget, possibly requiring new or higher taxes elsewhere or a
decrease in spending for other programs and activities.
Page 3 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
All 50 states require that virtually all children be vaccinated against
Background common childhood diseases before they enter school,4 and HHS reports
that over 12 million vaccinations are given to children each year. These
laws have dramatically reduced many infectious diseases in the United
States. For example, the number of reported cases of measles, which can
lead to brain damage and death, has dropped from about half a million in
1960 to about 100 in 1998. For most children, freedom from the effects of
measles, diphtheria, polio, tetanus, pertussis, and other diseases is a
decided benefit. But immunization programs also carry a human cost. A
small number of children who receive immunizations have serious and
unexpected reactions to them. These reactions can be devastating—
paralysis, permanent disability, and even death. Affected families without
adequate insurance coverage may face significant expenses, because the
costs for residential or home care, therapy, medical equipment, and drugs
needed to care for an injured child over a lifetime can exceed several
million dollars. Prior to VICP, families could seek compensation for
damages only through the civil tort system or through a settlement
agreement with the vaccine manufacturer or health care provider.
Filing a lawsuit in the civil tort system was considered to be unsatisfactory
for those claiming to have suffered an adverse reaction to a vaccine.
Petitioners had difficulty proving vaccine-related injuries because studies
and medical evidence needed to definitively link vaccines with various
medical conditions were often insufficient to establish the level of proof
required for compensation in the legal system.5 Establishing this link can
be difficult because most injuries that can be caused by vaccines can be
caused by other things as well. For example, symptoms of neurological
disorders often show up in the first year of life, which is the same time that
most vaccines are administered.
Petitioners are not the only ones who found the legal system difficult. As
the number of lawsuits increased, particularly for the DTP vaccine, vaccine
manufacturers became concerned not only with problems of time and
expense but also with the availability and affordability of product liability
insurance. The federal government, in turn, became concerned that if
4
States generally require vaccination against each of the original seven childhood diseases covered by
the program, but there is some variation. Six states, for example, do not require the pertussis vaccine
and six others do not require the mumps vaccine.
5
For example, the Institute of Medicine studied 75 specific relationships between vaccines and adverse
events and concluded that medical evidence was insufficient to prove or disprove a relationship in
two-thirds of the cases. See a discussion of Institute of Medicine studies in Research Strategies for
Assessing Adverse Events Associated With Vaccines: A Workshop Summary (National Academy Press,
1994).
Page 4 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
manufacturers withdrew from the market, vaccine shortages would result
and infectious diseases would reemerge as serious health threats.
VICP Represented a New VICP established a new system for vaccine injury compensation that was
Approach to Injury expected to be fair, simple, and easy to administer. Rather than filing a
Compensation lawsuit against the vaccine manufacturer or vaccine administrator in the
civil tort system, an individual claiming injury from vaccines covered by
the program must first file a petition for “no-fault” compensation with the
U.S. Court of Federal Claims.6 Special masters of the court—attorneys
appointed by the judges of the court—conduct informal hearings as
necessary to determine whether the petitioner is entitled to compensation
from VICP, and if so, how much. HHS, as overall administrator of VICP, is
represented by Department of Justice (DOJ) attorneys, while the petitioner
may be represented by a private attorney.7 (See app. II for a description of
the claims process.)
To ensure access to the program, VICP pays attorney fees and costs for the
petitioner, regardless of whether the petitioner is awarded compensation.8
VICP features designed to expedite the process include a relaxation of the
rules of evidence, discovery, and other legal procedures that can prolong
cases in the legal system. Features designed to control costs include a
legislated $250,000 payment for compensable deaths. For compensable
injuries, the program purchases annuities covering the lifetime costs of
care not covered by insurance and compensates for pain and suffering and
lost wages. VICP does not pay punitive damages. Compensation is available
for reasonable attorney fees and costs, which generally reflect the actual
time and expense devoted to the case.
Program’s Injury Table Is There are two ways a petitioner can qualify for compensation under VICP.
Its Most Important Feature Similar to the civil tort system, petitioners must be able to prove that a
vaccine caused an injury or, unique to VICP, the petitioner must have an
injury listed on the program’s injury table. The number of vaccines and
injuries listed on the table have changed over time. Legislation establishing
6
Lawsuits may be filed against manufacturers or health care providers if a petition is dismissed or
judged noncompensable under VICP and the judgment is rejected by the petitioner, if the award
granted by VICP is rejected by the petitioner, or if the vaccine is not covered under VICP.
7
The vaccine manufacturer and whoever administered the vaccine are not involved as parties to the
proceedings.
8
Attorney fees and costs are paid if the court determines there is a reasonable basis for the petition and
the petition was filed in good faith.
Page 5 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
the original injury table included five different medical conditions related
to vaccines against seven diseases (see table 1).
Table 1: Original Vaccine Injury Table
Vaccine and injurya Time periodb
Vaccines against diphtheria,c tetanus, and pertussis
Anaphylaxis 24 hours
Residual seizure disorder 3 days
Shock-collapsed 3 days
Encephalopathy 3 days
Vaccines against measles, mumps, and rubella
Anaphylaxis 24 hours
Residual seizure disorder 15 days
Encephalopathy 15 days
Vaccines against polio
Paralytic polioe 30 days/6 monthsf
g
Anaphylaxis 24 hours
Note: For current vaccine injury table, see app. III.
a
Injuries are defined in “Qualifications and Aids to Interpretation,” reprinted in app. III.
b
For first symptom, onset, or aggravation of injury after vaccination.
c
Administered with tetanus and/or pertussis vaccines.
d
For vaccines against pertussis.
e
Injury related to oral polio vaccine.
f
Time intervals are for immunocompetent/immunodeficient individuals who receive oral poliovirus.
Contact cases have no limit.
g
Injury related to inactivated polio vaccine.
Filing a claim using the injury table relieves petitioners from some of the
uncertainty caused by gaps in medical knowledge. Under VICP, vaccines on
the injury table are presumed to have caused the listed injury if incurred
within specific time periods. For example, under the original table,
someone suffering neurological damage from seizures within 3 days after
receiving a vaccine against pertussis would receive compensation if HHS
could not prove that the condition was due to factors unrelated to the
administration of the vaccine. Thus, for the petitioner, VICP’s injury table
may provide a benefit over the civil tort system.
Page 6 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
Funding for Compensation VICP finances awards and attorney payments differently, depending on
Has Come From Two when the vaccine causing the alleged injury was administered. For
Sources vaccines administered prior to October 1, 1988, payments are made from
general revenues appropriated by the Congress each year. For vaccines
administered on or after this date, payments are made from the VICP trust
fund, which is supported by a $.75 excise tax on each dose of vaccine sold9
and interest accumulating on the trust fund balance. As of February 1999,
VICP had paid close to $1 billion for awards and attorney payments—
75 percent from appropriated general funds rather than from the trust fund
(see table 2).
Table 2: Financing for VICP Claim
Payments Number of Awards/
claims filed attorney
as of Feb. paymentsa as
VICP claims Filing deadline Funding source 1999 of Feb. 1999
Vaccines Jan. 31, 1991 Annual 4,245 $742,244,679
administered appropriations
prior to Oct. 1,
1988
Vaccines Within 24 Vaccine excise tax 1,110b 250,296,568
administered on months from
or after Oct. 1, date of death or
1988 36 months from
date of injury
a
The maximum award paid was close to $8 million while the median paid was $318,943.
b
Includes five cases where the data field for date of vaccination was blank.
Processing VICP claims continues to take longer than expected. When the
Processing VICP Congress established VICP, the expectation was that the court would take 1
Claims Takes Longer year or less10 to judge whether a claim was entitled to compensation and,
Than Expected if so, how much that compensation would be. The program became
effective on October 1, 1988, and as of February 1999, 5,355 claims had
been filed. Of this number, about 14 percent received judgment within 1
year (see fig. 1). Most did not receive judgment within 2 years. Of the total
9
This uniform rate of taxation became effective Aug. 6, 1997 (P.L. 105-34). Prior to this date, the excise
tax rate varied by vaccine in accordance with the expected compensation payments associated with
each covered vaccine.
10
The original legislation required a judgment on claims no later than 365 days after the claim was filed.
This was subsequently amended to require a judgment by the special master within 240 days exclusive
of suspended time. Either party may appeal the decision to a judge of the court, which would add time
to the process. (See app. II.) If the special master fails to make a decision within 240 days or if
appealed and a judgment is not rendered within 420 days, petitioners are allowed to withdraw from
VICP and sue the manufacturer or health care provider directly.
Page 7 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
claims filed during this period, 10 percent had not received a judgment as
of February 1999 and remained open.
Figure 1: Status of VICP Claims
1 Year or Less
19% Between 1 and 2 Years
14%
39% Between 2 and 5 Years
10%
18% 5 Years or More
Pending Casesa
Closed Cases
Note: Data are for cases filed as of February 1999.
a
The length of time pending cases had been in process ranged from less than 1 month to more
than 8 years.
Two interrelated reasons are central to explaining these longer than
expected processing times. The first was a large influx of claims filed a
few years after the program began. The second was that as more funding
became available to defend claims, HHS increasingly challenged the ones it
regarded as not clearly meeting the statutory criteria.
Page 8 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
Delays Due to Volume When VICP took effect on October 1, 1988, it gave claimants 2 years and 4
months (until January 31, 1991) to file claims on injuries for vaccines
administered prior to October 1988. As people began responding to the
deadline, the number of claims filed under VICP jumped from 125 claims in
1989 to 3,263 claims in 1990. Nearly 800 more claims were filed in the
month before the deadline. As table 3 shows, this large influx of claims
created an immediate backlog. The number of pending claims rose to as
high as 3,548 at the end of 1991 and remained above 1,000 until the end of
1995.
Table 3: VICP Claims Filed,
Adjudicated, and Pending, by Calendar Year Claims filed Claims adjudicated Claims pending
Year 1988 79 0 79
1989 125 61 143
1990 3,263 153 3,253
1991 968 673 3,548
1992 174 735 2,987
1993 119 637 2,469
1994 121 612 1,978
1995 164 707 1,435
1996 92 573 954
1997 107 332 729
1998 131 309 551
1999a 12 25 538
Total 5,355 4,817
a
Data as of February 1999.
As might be expected, processing times began to increase as HHS worked
to respond to the influx of claims. Before 1990, nearly all claims were
processed within 2 years. Starting in 1990, however, only about 30 to
40 percent of claims filed each year have been processed this quickly (see
fig. 2).
Page 9 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
Figure 2: Percentage of Claims Filed in
Calendar Years 1988 to 1997 With 100
Judgment Received Within 2 Years
90
80
70
60
50
40
30
20
10
0
1988 1989 1990 1991 1992 1993 1994 1995 1996 1997
Percentage with judgment received in first year
Percentage with judgment received in second year
Note: Second-year data for 1997 are incomplete. In addition, only data for 1988 through 1991
include claims for vaccinations given prior to October 1988 because the filing deadline for such
claims was January 31, 1991. Data for 1992 through 1997 include claims for vaccinations on or
after October 1988.
Delays Due to Change in As figure 2 shows, the percentage of claims processed within 1 or 2 years
Program Implementation changed somewhat from year to year but has not increased much since
1992. Although table 3 shows that the number of claims filed since the
1991 deadline dramatically decreased, the number of claims adjudicated
generally declined in following years. A key reason is because in 1990, HHS
and DOJ began to increasingly scrutinize claims of vaccine injury as funding
to fully implement their legislated authority under the program became
available. DOJ established a cadre of attorneys specializing in vaccine
injury to represent HHS in hearings, and HHS established an expert witness
program to help assess whether alleged vaccine injuries such as seizure
disorders may have been present from birth or were due to other causes.
Full implementation of HHS’ statutory authority to defend claims had
implications for claims processing times, making it more difficult for
Page 10 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
claims to be processed within the 1-year period originally envisioned or
even a 2-year period. For example, HHS data show that more than half of all
petitioners were requested to provide supplementary medical records or
other information, and most took at least a year to do so. Both sides often
made use of expert witnesses to review the evidence and report on their
findings. After all the information was received, in most cases, it took the
court over another year to reach its decision.
Steps Taken to Expedite HHS, DOJ,and the U.S. Court of Federal Claims have taken some steps to
Claims Processing expedite the claims process, including the following:
• Since 1990, HHS has cut its average time for completing its medical review
and submitting its recommendation to the court from nearly 6 months11 to
about 3 months.
• In 1990, the court produced a guide for petitioners and their attorneys
explaining how to process claims through VICP, and in 1994, DOJ published
steps to expedite the resolution and payment of compensation and
attorney fees.
• Starting in the fall of 1997, the court initiated a practice of holding
conference calls between the special masters and attorneys within 30 to 45
days after the filing of a petition to discuss any deficiencies in the petition,
such as absence of pertinent medical records, and ways to remedy them.12
The chief special master said that while the court could process claims
more quickly, delays are granted primarily to benefit petitioners who need
more time to gather information, have medical tests performed, or identify
costs related to an injured child’s developmental needs. If a judgment is
not received within 240 days, petitioners can withdraw their claim from
VICP and file a lawsuit in the civil tort system. Yet HHS, DOJ, and court
officials stated that none have done so.
11
Data for 1990 are for claims relating to vaccines administered after Sept. 30, 1988. The 1990 average
for all claims is over 2 years.
12
For example, DOJ states that where appropriate, it will subpoena medical records on behalf of the
petitioner.
Page 11 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
Of the 4,817 petitioners receiving judgment under the program as of
Injury Table Changes February 1999, close to 30 percent received compensation for a family
May Increase member’s injury or death. Most compensated claims alleged injuries listed
Difficulty Petitioners on the program’s vaccine injury table. Since the program began, HHS has
made two sets of changes to the table, removing some injuries and adding
Face in Obtaining other injuries and vaccines. However, far more claims are associated with
Compensation for injuries removed from the table than with injuries that were added. As a
result, more petitioners now must prove that a vaccine caused the injury,
Vaccine-Related rather than HHS having to prove that the injury was due to factors
Injuries unrelated to the vaccine.
Number of Petitioners Most of the petitioners who filed claims and received awards under VICP
Potentially Covered by the alleged injuries listed on the program’s vaccine injury table. Petitioners
Vaccine Injury Table Has who did not claim injuries listed on the injury table—about
28 percent—had the burden of proving that a vaccine caused the injury; of
Decreased these petitioners, only 13 percent were able to obtain compensation. The
remaining 72 percent claiming injuries on the table had compensation
rates nearly three times higher.
Table 4: VICP Petitions Claiming
Table/Off-Table Injuries Percent table claims Percent off-table claims
Vaccine Filed Compensated Filed Compensated
Vaccines against diphtheria, 83 32 17 15
tetanus, and pertussis
Vaccines against measles, mumps, 53 43 47 25
and rubella
Vaccines against polio 39 60 61 3
a a
Vaccines against hepatitis B 7 93
b a
Vaccines against varicella 0 100
b
Unspecified/nonqualifying 0 100 0
Total 72 35 28 13
a
Judgment pending.
b
Not applicable.
Under the act that created VICP, HHS has rulemaking authority to change the
injury table and has done so on two occasions. The act established the
first injury table, with HHS to make future changes as more information
became available. The act further called for the Institute of Medicine, of
the National Academy of Sciences, to assist HHS in this regard by reviewing
existing medical studies and literature related to a set of specific
Page 12 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
conditions that might be related to vaccines covered by the program. After
the reviews were completed in 1991 and 1994, the Institute of Medicine
identified certain conditions that were consistent or inconsistent with a
causal relationship, those that favored or did not favor a causal
relationship, and those where evidence was insufficient to indicate the
presence or absence of a causal relationship.13 HHS used these findings—in
conjunction with public policy considerations provided by the Advisory
Commission on Childhood Vaccines, scientific issues raised by its National
Vaccine Advisory Committee, and input from the public—to add seven
injuries and remove three others from the table in 1995 and 1997 (see table
5).14 In addition, HHS refined the supporting guidance to the table,
“Qualifications and Aids to Interpretation.” This document provides
definitions for injuries and the specific circumstances under which the
table injuries must occur (see app. III for the current injury table and
interpretation aids).
Table 5: Injuries Added to and
Removed From the VICP Vaccine Vaccine Injury added Injury removed
Injury Table Effective Mar. 10, 1995
Vaccines against pertussis Shock-collapse
Vaccines against pertussis Residual seizure disorder
and tetanus
Vaccines against rubella Chronic arthritis
Effective Mar. 24, 1997
Vaccines against measles, Residual seizure disorder
mumps, and rubella
Vaccines against measles — Thrombocytopenic
purpura
— Vaccine-strain measles
Vaccines against polioa Vaccine-strain polio
Vaccines against hepatitis B Anaphylaxis
Vaccines against hemophilus Early-onset Hib
influenzae type b (Hib)
Vaccines against tetanus Brachial neuritis Encephalopathy
a
Applies to oral polio vaccine.
13
Most conditions fell in the third category, as the Institute of Medicine concluded that there was
insufficient medical evidence to prove or disprove a relationship between vaccines and two-thirds of
the 75 medical conditions studied.
14
HHS publishes the proposed and final rules of injury table changes in the Federal Register. HHS must
allow 180 days for public comment on a proposed rule. HHS must also provide 90 days for review of
proposed rule by the Advisory Commission on Childhood Vaccines, comprised of parents of injured
children, health professionals, and attorneys appointed by HHS. The National Vaccine Advisory
Committee is comprised of representatives from state and local health departments, vaccine
companies, academia, and consumer groups.
Page 13 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
Although HHS added more injuries than it removed from the original injury
table, fewer petitioners now have the potential to use it. Where 74 percent
of petitioners filed claims alleging injuries on the injury table prior to the
1995 and 1997 changes, only 55 percent filed such claims after the table
was revised.15 To some extent, this decrease is because more claims were
associated with the injuries removed from the table than were associated
with the injuries that were added. Significantly, as shown in table 6, about
45 percent (611) of the 1,368 claims awarded compensation under VICP
were for injuries subsequently removed from the table. These claims
accounted for about half of the $974 million awarded thus far under the
program. These numbers are significant because petitioners with injuries
not listed on the injury table historically have had a lower probability of
being compensated than those with injuries that were listed.
Table 6: Claims Associated With Injuries Added to and Removed From the VICP Vaccine Injury Table
Claims for injuries added to injury Claims for injuries removed from
table injury table
Number Number
Vaccine Injury compensated Total awarded compensated Total awarded
a a
Vaccines against rubella Chronic arthritis 9 $622,101
a a
Vaccines against tetanus Brachial neuritis 0 0
Vaccines against measles Thrombocytopenic
a a
purpura 0 0
a a
Vaccines against measles Vaccine-strain measles 0 0
a a
Vaccines against polio Vaccine-strain polio 0 0
a a
Vaccines against hepatitis B Anaphylaxis 0 0
Vaccines against hemophilus Early-onset Hib
a a
influenzae type b (Hib) 0 0
a a
Vaccines against pertussis Shock-collapse 61 $27,228,905
Vaccines against measles, Residual seizure
mumps, pertussis, rubella, disorder
a a
and tetanus 547 452,141,726
a a
Vaccines against tetanus Encephalopathy 3 529,074
Total claims compensated/amounts awarded for injuries added/removed from the table
9 $622,101 611 $479,899,705
Percent of all claims compensated/amounts awarded
0.7 0.0 44.7 49.3
a
Not applicable.
15
The actual percentages of claims qualifying as table injuries are lower due to restrictions in the
definition of an injury or time of onset listed in “Qualifications and Aids to Interpretation.” (See app.
III.)
Page 14 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
Lack of Clear Methodology HHS has published its rationale for each revision to the injury table in the
for Table Changes Raises Federal Register but has not published an overall method of applying the
Questions of Consistency criteria it uses in conjunction with the Institute of Medicine findings.
Because HHS’ modifications of the table determine whether the
government or petitioner has the burden of proof for affected claims, table
changes that make compensation more difficult for petitioners have been
questioned by some. Defining the criteria related to the level of program
and financial risk that the government will bear is controversial and there
is disagreement about what the Congress intended in this regard. For
example, HHS interprets the legislative history as directing it to recognize
table injuries where there is definitive information linking vaccines to
injuries, while others cite the same legislative history as directing that,
until definitive information is available, the benefit of doubt should remain
with the petitioner.
Particularly because of these differences, establishing a clearly defined,
transparent decisionmaking process is important to help advance the
appearance of fairness. HHS has not produced such a methodology, and its
actions do not always convey a sense of consistency, as illustrated in the
following examples:
• The Institute of Medicine found that existing scientific evidence favored
acceptance of a causal relationship between tetanus vaccines and brachial
neuritis, and HHS added that condition to the injury table. On the other
hand, the Institute also found evidence of a causal relationship between
the tetanus and oral polio vaccines and Guillain-Barre syndrome, but HHS
did not add this condition to the injury table.
• The Institute of Medicine found the evidence inadequate to accept or
reject a causal relation between vaccines and residual seizure disorder,
and HHS removed this condition from the injury table. The Institute also
found evidence inadequate to accept or reject a causal relation between
the measles and mumps vaccines and encephalopathy, yet HHS left this
condition on the injury table.16
HHS stated in the Federal Register that decisions not to add injuries, such
as Guillain-Barre syndrome, or to remove injuries, such as residual seizure
disorder, were based to some extent on the level of risk in compensating
an inordinate number of non-vaccine-related cases for the extremely rare
vaccine-related case. In applying this criterion, however, HHS’ assumptions
about the number of potential claims and thresholds for deciding the
16
HHS narrowed the definition of encephalopathy in the “Qualifications and Aids to Interpretation,”
which would preclude use of the table for some petitioners.
Page 15 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
reasonable level of financial risk for compensating non-vaccine-related
injuries were not defined.
The VICP trust fund has grown to $1.3 billion primarily because the income
Trust Fund Income from vaccine excise taxes is higher than claims payments and because the
Exceeds Need for government pays interest on the trust fund balance. Program participants
Claims Payments have expressed concerns about the rising balance and have proposed
options to address them. Exercising these options, however, would have
implications for the overall federal budget, possibly requiring new or
higher taxes elsewhere or a decrease in spending for other federal
programs and activities.
VICP Trust Fund Continues The VICP trust fund has historically received more in vaccine excise taxes
to Grow than it has paid out for claims and related administrative costs. Since the
program began, the Treasury reported it has collected over $1.6 billion in
vaccine excise taxes: $.4 billion of this amount went directly to the general
fund to offset income and payroll taxes lost to the general fund as a result
of the excise tax.17 The remaining $1.2 billion went to the VICP trust fund
for claims payments and related administrative costs. Because the trust
fund has spent only about $290 million of the $1.2 billion received, the
remaining $948 million was loaned to the Treasury and used for other
federal programs and activities. In exchange, the trust fund received
Treasury securities to be redeemed if needed to pay future claims.18
Interest on these Treasuries held by the trust fund totaled about
$374 million by the end of fiscal year 1998. This $374 million in interest and
the $948 million loaned to the Treasury comprise the $1.3 billion trust fund
balance existing as of the end of fiscal year 1998.
17
The 25-percent factor is the standard offset used when excise tax provisions are scored for budget
purposes during the legislative process. Budget estimating conventions are that gross domestic
product and the price level are fixed. Therefore, any increase in excise taxes must reduce payments to
labor and capital (such as wages and rents) and, therefore, reduce income and payroll taxes deposited
to the general fund.
18
As provided in section 9602(b) of the Internal Revenue Code for management of trust funds in
general.
Page 16 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
Figure 3: Money Flows Attributable to
Vaccine Excise Taxes Collected From
Fiscal Year 1989 Through Fiscal Year
1998
Excise Tax on Each
Dose of Vaccine
$1.2 Billion $.4 Billion
Unused Surplus
$.9 Billion
Vaccine Injury
General Fund
Compensation
Program Trust Fund
Special Treasuries
$.9 Billion
Interest Paid on Special
Treasuries
$.4 Billion
$.3 Billion
Injury Claims and
Administrative Costs
At current rates, the Congressional Budget Office (CBO) estimates that the
VICP trust fund balance will reach $2.6 billion within the next decade and
Page 17 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
the program will generate almost three times more revenue than will be
used to pay annual claims and administrative costs. However, the vaccine
excise tax rate is not based on an empirical risk assessment set to fund
future benefits, and HHS officials do not believe that there is an outstanding
liability requiring a large trust fund balance to meet future claims
payments.19 If this expectation holds true, the trust fund balance reflects
the amount of vaccine excise taxes and interest on Treasury securities that
is not expected to be needed for VICP purposes.
Options to Address Vaccine manufacturers, parent groups, and others involved with VICP have
Concerns About the expressed concerns about the large trust fund balance and have proposed
Growing Trust Fund options to address them. These options generally involve cutting the
excise tax supporting the trust fund or spending more of the money
Balance received on designated vaccine-related activities. Views and options
include the following:
• Some vaccine manufacturers view the trust fund balance as an indicator
that the vaccine excise tax rate is too high. They support legislative
proposals to reduce the tax rates.
• Parent groups view the trust fund balance as an indicator of the
government’s unwillingness to recognize vaccine injuries and compensate
people fairly for these injuries. They advocate a less restrictive injury table
that would increase the number of petitioners compensated from the trust
fund.
• HHS officials from the Food and Drug Administration (FDA) and the Centers
for Disease Control and Prevention (CDC) responsible for monitoring
vaccine safety view the trust fund balance as a source of potential revenue
if the Congress decides to expand trust fund spending to vaccine-related
activities. Although the Administration has not submitted formal proposals
to increase support of these activities or taken a position on the potential
use of the trust fund, FDA and CDC officials we contacted supported
dedicating a portion of the trust fund revenue not needed for claims
payment to provide funding for vaccine injury surveillance systems and for
research examining links between vaccines and delayed onset or chronic
diseases.
Budgetary Implication of Because excise tax revenue received by the VICP trust fund and not spent
Options to Reduce the on the program is invested in Treasury securities and these proceeds are
Trust Fund Balance used by the general fund, implementing options to control the growth of
19
See Budget Issues: Budgeting for Federal Insurance Programs (GAO/AIMD-97-16, Sept. 30, 1997) for
further information on budget issues for federal insurance programs.
Page 18 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
the trust fund balance not only affect the trust fund but also affect revenue
and spending for the overall federal budget. Options requiring a change in
legislation are also affected by requirements of the Budget Enforcement
Act (BEA).20 Under BEA, the Congress has to offset the cost of legislation
that reduces revenue or increases spending by establishing new or higher
taxes elsewhere or by decreasing spending for other programs.21 For
example, if the Congress had passed a law in 1998 that either lowered the
vaccine excise tax rate to match claims payments or allowed the trust fund
to spend the annual excess for new activities, funding for other federal
programs and activities would have to have been reduced by $59 million.22
Had legislation been enacted in 1998 allowing new spending beyond the
annual income received by the trust fund, the trust fund would have had to
draw upon the $1.3 billion trust fund balance by redeeming its Treasury
securities. In this case, BEA would have required a reduction in spending
for other federal programs—or an increase in other taxes—to offset the
new spending by the trust fund.
While VICP was expected to provide compensation for vaccine-related
Conclusions injuries quickly and easily, these expectations have often not been met. In
establishing the vaccine injury table as a desirable alternative for
petitioners over the civil tort system, the Congress was initially willing to
accept the risk that some compensation would be provided for injuries
where the role of vaccines is uncertain. But in administering and refining
the injury table, HHS is in the position of determining how much of this
uncertainty the program will continue to bear. When HHS removes or does
not add injuries to the vaccine injury table, the petitioner bears the burden
of proof rather than the government. Where science is insufficient to
determine causal relationships between a vaccine and injuries, it is not
clear that HHS’ criteria and approach to making injury table changes are
consistent. Establishing a standard method with criteria that will be used
consistently for all table changes may help eliminate questions regarding
HHS’ programmatic decisions.
20
The Budget Enforcement Act of 1990 and subsequent amendments (the Omnibus Budget
Reconciliation Act of 1993 and the Budget Enforcement Act of 1997) are collectively referred to as the
Budget Enforcement Act. These acts amended the Balanced Budget and Emergency Deficit Control
Act of 1985, sometimes called Gramm-Rudmann-Hollings.
21
The act requires that all legislation that increases mandatory spending or decreases receipts be fully
offset—or paid for—so that it is deficit neutral. The Balanced Budget Act of 1997 requires that the
impact of spending and receipts legislation be offset in the current year, the budget year, and the
following 4 fiscal years. A point of order may be raised in the Senate if the change is not deficit neutral
in the second 5 years. This provision is enforced through sequestration, which is done annually.
22
This result assumes that if vaccine excise taxes were reduced, the manufacturer would not decrease
vaccine prices to pass on the tax savings to purchasers. If the tax savings were passed on to the
vaccine purchaser, funding for other federal programs would need to have been reduced by
$30 million.
Page 19 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
We recommend that the Secretary of HHS develop and apply a consistent
Recommendation to methodology for evaluating and reporting on the various factors used to
the Secretary of HHS add injuries to or remove injuries from VICP’s injury table. This
methodology should include specific scientific and public policy
considerations and their relative weight in the decisionmaking process and
should be applied to any future table changes.
Both HHS and DOJ provided written comments on our draft report. Their
Agency Comments comments are reprinted as appendix IV and appendix V, respectively. We
and Our Evaluation summarized their comments and provide our response below.
Both HHS and DOJ raised issues with our analysis of claims processing
times. In addition, HHS did not concur with our recommendation regarding
the need to establish a clear methodology for revising the vaccine injury
table and said that the Administration has not taken a position on potential
uses of the VICP trust fund surplus.
Claims Processing Times HHS commented on what it considered an inappropriate use of the original
legislated criteria of 1 year to measure VICP performance. HHS pointed out
that subsequent legislation allows petitioners additional time, as needed,
to obtain medical records and bolster the sufficiency of their cases. We
made several modifications to the final report to reduce the perceived
focus on historical expectations. Nevertheless, while the legislation was
amended to provide petitioners with the flexibility to keep the case open
longer, there is no indication that the Congress changed its expectation
that claims would be processed quickly. In fact, the law was amended to
require a special master decision within 240 days, exclusive of suspended
time.23
HHS also commented that our analysis should more clearly differentiate
adjudication times between claims related to vaccinations administered
prior to October 1988 (pre-1988 claims) and claims related to vaccinations
on or after this date (post-1988 claims). HHS stated that pre-1988 claims are
not representative of current and future processing times and should be
reported on separately. HHS said the average processing time for post-1988
claims was 2 years. To clarify that our analysis did differentiate between
pre- and post-1988 claims, we added a note to figure 2 to indicate that the
years 1992 through 1997 include only post-1988 claims. We also note that
23
Either party may file an appeal of the special master decision, which would add time to the process
(see app. II).
Page 20 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
HHS’ 2-year number is the average time for only those cases that have been
closed. However, after 2 years, a majority of the cases filed each year are
still open.
HHS and DOJ said that the draft report implied that HHS’ increased
propensity to defend claims is a result of a significant change of position
rather than the result of the Congress providing funding for DOJ attorneys
to defend claims that HHS had defaulted on for the first 2 years of the
program. We added language to clarify that HHS’ increased level of defense
in implementing its statutory authority was related to the availability of
additional resources.
DOJ also commented that some statements in the draft may convey an
incorrect understanding of why some cases have taken longer to resolve
than originally anticipated. DOJ said a significant factor was that the court
suspended claims processing in 1991 when an overwhelming number of
claims were received. Legislation does allow the court to suspend
proceedings when the volume of claims is onerous, and our report does
state that the large volume of cases was a primary factor in delayed
processing times. However, we also point out that volume is not the only
factor. For example, we report that even though caseloads declined
between 1992 and 1997, the percentage of new claims processed within 2
years has remained relatively the same. We have added wording to the
report text to help clarify this point.
HHS also pointed out that our draft report did not discuss recent legislative
proposals to improve VICP. In our view, the legislative proposals advanced
by HHS in June 1999 do not directly address the findings related to our
report objectives; therefore, we did not include them. The proposals
primarily cover technical aspects of the program, such as expanding the
statute of limitations for filing claims and clarifying statutory terms that
define entitlement to compensation.
Vaccine Injury Table HHS did not concur with our recommendation that in considering future
changes to the vaccine injury table, HHS formalize and apply a set of
standard criteria for making decisions to add or remove injuries. HHS
stated that it is inappropriate to reduce the scientific basis for decisions to
the application of weighted criteria and that a standard approach in
making such decisions is not possible because the scientific and public
policy considerations vary on a case-by-case basis. Further, HHS stated that
the Institute of Medicine had cautioned against using a “formula”
Page 21 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
approach, and HHS had gone to great lengths to explain its rationale for
each table decision when it published the proposed and final rules in the
Federal Register.
We recognize that HHS has a difficult task of applying judgment when
scientific uncertainties exist about the causal links between vaccines and
injuries, and we did not question the table changes that were made.
However, using a variety of criteria on a case-by-case approach does not,
in our view, clearly communicate to the public that HHS is acting
consistently in applying its judgment. For example, in discussing its
rationale for each change in the Federal Register, HHS generally cites some
combination of four factors in controlling its decision. These factors
include Institute of Medicine findings (and subsequent medical studies),
biologic plausibility, recommendations from the Advisory Council on
Childhood Vaccines and the National Vaccine Advisory Committee, and
prevalence of the condition in the population attributable to vaccines.
However, in communicating its decisions to the public, HHS does not
uniformly discuss each of these factors, and the reasons why the relative
importance of each factor varies among the decisions is not apparent in all
cases. As HHS indicated in its comments, it is important to maintain public
confidence in the fairness of the program. Our recommendation is being
made with this objective in mind.
Further, we disagree that it is not practical for HHS to adopt a standard
methodology to evaluate the available evidence and that doing so would
constitute use of a formula. For example, the Institute of Medicine
developed such a methodology to perform its review and evaluation of the
available scientific evidence linking vaccines to adverse events. The
Institute considered four types of scientific evidence (biologic plausibility,
case reports, case series, and uncontrolled observational studies) and used
qualitative and quantitative approaches to weight each type of evidence.
The results were summarized in a matrix with narrative on how each
factor was applied in the decisionmaking process. HHS could develop a
similar decisionmaking methodology that includes the public policy
considerations and other relevant criteria it uses in addition to the
Institute’s findings. We have reworded our recommendation to make it
clearer that, in the future, HHS should apply a consistent methodology for
evaluating and reporting on the factors used to make vaccine injury table
changes.
HHSalso commented that the reason compensation numbers significantly
dropped for DTP after the vaccine injury table changes was not because of
Page 22 GAO/HEHS-00-8 Vaccine Injury Compensation Program
B-281968
the table changes, as we reported, but because of a decrease in the use of
this vaccine. HHS also stated that our report should reflect the fact that
VICP’s future workload will be primarily for vaccines other than DTP. Our
point about the changes to the table does not relate to the use of the DTP
vaccine or VICP’s workload. Instead, our discussion concludes that,
regardless of the vaccine in question, people have historically had a higher
chance of being compensated for injuries that are on the table than for
injuries that are not on the table. Since a higher percentage of people filed
claims off-table after the table changes were implemented, the future
percentage of claims compensated under the program may be lower.
Trust Fund Growth HHS said the Administration has not submitted formal proposals to
increase support of vaccine safety and research activities or taken a
position on the potential use of the trust fund. We have added language to
clarify that these options have not been formally endorsed by the
Administration.
As agreed with your office, unless you publicly announce its contents
earlier, we plan no further distribution of this report until 30 days from the
date of this letter. At that time, we will send copies of this report to the
Honorable Donna E. Shalala, Secretary of HHS; the Honorable Janet Reno,
Attorney General; the Honorable Loren A. Smith, Chief Judge, U.S. Court
of Federal Claims; and other interested parties. We will also make copies
available to interested congressional committees and others upon request.
This report was prepared by Frank Pasquier, Assistant Director; Lacinda
Baumgartner; and Linda Bade. Please call me at (202) 512-7118 if you or
your staff have any questions.
Sincerely yours,
Kathryn G. Allen
Associate Director, Health Financing
and Public Health Issues
Page 23 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Contents
Letter 1
Appendix I 26
Scope and
Methodology
Appendix II 29
VICP Claims Process
Appendix III 32
Current VICP Injury
Table and
“Qualifications and
Aids to Interpretation”
Appendix IV 38
Comments From the
Department of Health
and Human Services
Appendix V 43
Comments From the
Department of Justice
Tables Table 1: Original Vaccine Injury Table 6
Table 2: Financing for VICP Claim Payments 7
Table 3: VICP Claims Filed, Adjudicated, and Pending, by 9
Calendar Year
Table 4: VICP Petitions Claiming Table/Off-Table Injuries 12
Table 5: Injuries Added to and Removed From the VICP Vaccine 13
Injury Table
Table 6: Claims Associated With Injuries Added to and Removed 14
From the VICP Vaccine Injury Table
Table II.1: Claims Process Steps and Time Frames 30
Table III.1: VICP Vaccine Injury Table 32
Page 24 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Contents
Figures Figure 1: Status of VICP Claims 8
Figure 2: Percentage of Claims Filed in Calendar Years 1988 to 10
1997 With Judgment Received Within 2 Years
Figure 3: Money Flows Attributable to Vaccine Excise Taxes 17
Collected From Fiscal Year 1989 Through Fiscal Year 1998
Figure II.1: Time Line of VICP Claims Processed in U.S. Court of 31
Federal Claims Without an Appeal
Figure III.1: “Qualifications and Aids to Interpretation” 33
Abbreviations
BEA Budget Enforcement Act
CBO Congressional Budget Office
CDC Centers for Disease Control and Prevention
DOJ Department of Justice
DTP diphtheria, tetanus, and pertussis
FDA Food and Drug Administration
HHS Department of Health and Human Services
VICP Vaccine Injury Compensation Program
Page 25 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix I
Scope and Methodology
To obtain information on VICP, we interviewed (1) officials at HHS, DOJ, and
the U.S. Court of Federal Claims involved in the VICP claims process; (2) a
representative of the Institute of Medicine responsible for analyzing
existing scientific evidence for HHS use in revising the VICP vaccine injury
table; (3) officials at CDC and FDA responsible for the national immunization
program and monitoring vaccine safety; (4) an attorney and a parent group
representing the interests of people injured by vaccines; (5) a
representative of a professional association representing pediatric
physician interests; (6) Treasury officials responsible for the financial
accounting and reporting for the VICP trust fund; and (7) the CBO official
responsible for budgeting aspects of the trust fund and presentation in the
federal budget.
We also reviewed relevant legislation, financial reports, budget
documents, and reports evaluating various aspects of VICP operation. We
obtained and analyzed data from HHS on claims filed under VICP from 1988
to February 1999. In addition, we obtained the Federal Register notices
discussing HHS changes to the VICP injury table and reviewed the Institute
of Medicine’s analysis of information available to link vaccines to various
medical conditions.
We conducted our work from January through September 1999 in
accordance with generally accepted government auditing standards.
Claims Processing To determine how long it took to process claims through VICP, we analyzed
HHS’ VICP claims database. This database included data fields on when the
claim was filed and a history of processing steps through when the claim
was settled. We did not perform a reliability assessment of the data
system.
The Effect of Table We used HHS’ VICP claims database to identify compensation rates for
Changes on Compensation claims that did and did not allege injuries on the vaccine injury table. We
Rates identified such claims by comparing injuries on the injury table with those
listed in the HHS claims database for each claim. We provided a list of the
injuries in the database to HHS officials, and they confirmed those injuries
that they would consider as potentially being on or off each of the three
injury tables. Because three different injury tables were in effect over the
life of the program, we first grouped the claims according to the injury
table that was applicable at the time the claims were filed. We then
computed the number and proportion of claims in each group that did or
Page 26 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix I
Scope and Methodology
did not allege injuries on the injury table. Compensation rates and
associated awards for alleged table and non-table claims were then
identified using the data fields for the U.S. Court of Federal Claims’
judgment and award amounts in the HHS database.
Budgetary Effect of To determine the budgetary effect of options proposed to reduce the trust
Options to Address fund balance, we first obtained financial statements for the VICP trust fund
Growing Trust Fund from the Treasury. These financial statements identified the revenue that
flowed into the trust fund from vaccine excise taxes and interest accrued
Balance on Treasury securities, as well as expenditures that flowed out of the trust
fund for claims and associated administrative expenses. We did not audit
the trust fund financial statements.
Because of the interrelationship between the trust fund and the general
fund in the federal budget, we used the trust fund financial information to
identify the amounts that flowed directly and indirectly through the
Treasury to the general fund as a result of the program. Direct general
fund revenue includes 25 percent of all vaccine excise taxes collected by
the Treasury. As discussed with Treasury and CBO officials, we backed into
the total tax collected by the Treasury by dividing the vaccine excise tax
provided to the VICP trust fund by 75 percent. We then subtracted the trust
fund share of the tax from the total tax collected to get the amount of tax
available to finance general fund programs and activities. Indirect general
fund revenue includes amounts derived from Treasury securities issued to
the trust fund. The Treasury securities balances were listed on the trust
fund financial statements.
To demonstrate how proposed legislative changes to reduce the excise tax
rate or increase trust fund spending would affect the overall budget, we
used a rolling average of trust fund revenue and expenses in 1997 and 1998
(hereafter referred to as 1998). We used a rolling average to minimize
timing differences in accounting for revenue and expenses. We assumed
that if new legislation had resulted in a match between trust fund revenues
and expenditures in 1998, the amount of offset required by the Budget
Enforcement Act for 1998 would have been the difference between the
total excise tax actually received and expended by the trust fund in that
year.24 Our computation reflects the assumption that vaccine
manufacturers would not decrease vaccine prices to pass on the tax
savings to vaccine purchasers because HHS officials said that they did not
24
This excludes loss of the 25 percent in vaccine excise taxes provided directly to the general fund
because budget scoring convention assumes these taxes will be recouped through commensurate
increases in income and payroll tax revenue.
Page 27 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix I
Scope and Methodology
reduce prices when VICP took on the burden of liability. However, we also
computed the somewhat lesser effect on the general fund if the
manufacturer had passed on the savings. The effect is less because CDC
information on federal vaccine purchases shows that nearly half of all
vaccine purchases are made by the federal government. Therefore, lower
vaccine prices to federal agencies purchasing vaccines would offset the
decrease in excise tax. We computed the government’s loss as the
percentage of excess in the trust fund that was related to state and private
vaccine purchases.
Page 28 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix II
VICP Claims Process
Three federal agencies are involved in the VICP claims process: HHS, DOJ,
and the U.S. Court of Federal Claims. The process consists of several
steps. (See table II.1.)
Page 29 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix II
VICP Claims Process
Table II.1: Claims Process Steps and Time Frames
Step Time frame
Petition filed
An individual or representative claiming injury or death from a — In the case of an injury, the claim must be filed within 36
vaccine files a petition for compensation with the court. months after the first symptoms appeared, and the effects must
have continued at least 6 months after vaccination.
— In the case of a death, the claim must be filed within 24
months of the death and within 48 months after the onset of the
vaccine-related injury causing the death.
Physician review
A physician at the Division of Vaccine Injury Compensation, HHS, — Court rules require the report to be sent to the court within 90
reviews each petition to determine whether it meets the medical days from the date the claim was filed. This deadline is subject to
criteria for compensation. This recommendation is provided to the change depending on a petitioner’s ability to obtain all relevant
court through a report filed by DOJ, although it is not binding. medical records and file a complete petition.
Special master decision
A “special master” of the court is required to make the initial The special master is required to issue a judgment within 240
decision for compensation under the program. A special master is days (exclusive of suspended time) from the date a claim is filed,
an attorney appointed by the judges of the court. At hearings before or petitioners are allowed to withdraw their claim from VICP and
the special master, HHS is represented by a DOJ attorney and the file a lawsuit against the vaccine manufacturer or vaccine
petitioner is represented by a private attorney. administrator in the civil tort system.
Acceptance or rejection of special master decision
The petitioner and HHS accept or reject the special master’s — Either party has 30 days to file a motion for review by the
decision. court. If a motion is filed, an additional 30 days is provided to the
other party to respond.
— Instead of filing a motion for review, if a petitioner files an
election to reject a special master’s judgment within 90 days after
entry of judgment, the petitioner may proceed to file a lawsuit in
the civil tort system.
Court judgment
The court issues a judgment on the special master’s decision. — The court is required to enter a judgment within 420 days from
the date the claim was filed (exclusive of the time spent on
remand to the special master).
— Within 60 days, either party may file a petition for review of the
judgment with the U.S. Court of Appeals for the Federal Circuit.
Final appeal from the Federal Circuit is to the U.S. Supreme Court
through a petition seeking a writ of certiorari. Within 90 days of
the conclusion of the appeals process, if a petitioner files with the
court an election to reject the judgment, the petitioner may
proceed to file a lawsuit in the civil tort system. If the petitioner
takes no action within 90 days, the judgment is deemed
“accepted” by law.
Payment of award
Petitioners accepting the judgment and awarded compensation are Agency criteria requires HHS to pay petitioners within 60 days
paid from the VICP trust fund if the vaccine was administered on or after payment is authorized by the court and DOJ.
after October 1, 1988, or from annual appropriations if administered
before this date.
Page 30 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix II
VICP Claims Process
Figure II.1: Time Line of VICP Claims
Processed in U.S. Court of Federal
Claims Without an Appeal
Deadline for Deadline
Deadline special for Deadline to
for HHS to master of U.S. petitioner authorize
complete U.S. court to court to accept payment if
Petitioner medical reach a finalizes or appeal judgment
files claim review decision a judgment b judgment c accepted
0 90 240 270 360 420
Elapsed time (days)
a
Parties can request suspensions adding up to 180 days to the time before the special master
reaches a decision. In addition, for claims related to vaccines administered before Oct. 1, 1988,
the special master can suspend proceedings an additional 900 days.
b
Parties may expedite this step by waiving their right to file a motion for review. If parties file a
motion for review of the special master’s decision, the deadline for the court to render judgment is
extended by 150 days.
c
The petitioner may expedite this step by immediately electing judgment.
Page 31 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix III
Current VICP Injury Table and
“Qualifications and Aids to Interpretation”
Table III.1: VICP Vaccine Injury Table
Vaccine Injury/adverse eventa Time periodb
Tetanus-containing Anaphylaxis or anaphylactic shock 4 hours
Brachial neuritis 2-28 days
Pertussis-containing Anaphylaxis or anaphylactic shock 4 hours
Encephalopathy (or encephalitis) 72 hours
Measles, mumps, rubella in any combination Anaphylaxis or anaphylactic shock 4 hours
Encephalopathy (or encephalitis) 5-15 days
Measles-containing Thrombocytopenic purpura 7-30 days
Vaccine-strain measles in an immunodeficient recipient 6 months
Rubella-containing Chronic arthritis 7-42 days
Polio live virus-containing Paralytic polio
—In a nonimmunodeficient recipient 30 days
—In an immunodeficient recipient 6 months
—In a vaccine-associated community case Not applicable
Vaccine-strain polio viral infection
—In a nonimmunodeficient recipient 30 days
—In an immunodeficient recipient 6 months
—In a vaccine-associated community case Not applicable
Polio inactivated virus-containing Anaphylaxis or anaphylactic shock 4 hours
Hepatitis B Anaphylaxis or anaphylactic shock 4 hours
Hemophilus influenzae type b (Hib), unconjugated Early-onset Hib disease 7 days
Hib, conjugated No condition specified Not applicable
Varicella No condition specified Not applicable
Rotavirus No condition specified Not applicable
New vaccines recommendedc No condition specified Not applicable
a
Injuries also include any acute complication or sequela (including death) of the listed events (for
all but the conjugated Hib, varicella, and new vaccines).
b
For first symptom, onset, or aggravation of injury after vaccination.
c
Any new vaccine recommended by CDC for routine administration to children, after publication
by the Secretary of HHS of a notice of coverage.
Page 32 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix III
Current VICP Injury Table and
“Qualifications and Aids to Interpretation”
Figure III.1: “Qualifications and Aids to
Interpretation”
Page 33 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix III
Current VICP Injury Table and
“Qualifications and Aids to Interpretation”
Page 34 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix III
Current VICP Injury Table and
“Qualifications and Aids to Interpretation”
Page 35 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix III
Current VICP Injury Table and
“Qualifications and Aids to Interpretation”
Page 36 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix III
Current VICP Injury Table and
“Qualifications and Aids to Interpretation”
Page 37 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix IV
Comments From the Department of Health
and Human Services
Page 38 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix IV
Comments From the Department of Health
and Human Services
Now on p. 2.
Page 39 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix IV
Comments From the Department of Health
and Human Services
Now on p. 11.
Now on p. 2.
Page 40 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix IV
Comments From the Department of Health
and Human Services
Now on p. 15.
Page 41 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix IV
Comments From the Department of Health
and Human Services
Now on p. 18.
Now on p. 15.
Page 42 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix V
Comments From the Department of Justice
Page 43 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Appendix V
Comments From the Department of Justice
(108396) Page 44 GAO/HEHS-00-8 Vaccine Injury Compensation Program
Ordering Information
The first copy of each GAO report and testimony is free.
Additional copies are $2 each. Orders should be sent to the
following address, accompanied by a check or money order
made out to the Superintendent of Documents, when
necessary. VISA and MasterCard credit cards are accepted, also.
Orders for 100 or more copies to be mailed to a single address
are discounted 25 percent.
Orders by mail:
U.S. General Accounting Office
P.O. Box 37050
Washington, DC 20013
or visit:
Room 1100
700 4th St. NW (corner of 4th and G Sts. NW)
U.S. General Accounting Office
Washington, DC
Orders may also be placed by calling (202) 512-6000
or by using fax number (202) 512-6061, or TDD (202) 512-2537.
Each day, GAO issues a list of newly available reports and
testimony. To receive facsimile copies of the daily list or any
list from the past 30 days, please call (202) 512-6000 using a
touchtone phone. A recorded menu will provide information on
how to obtain these lists.
For information on how to access GAO reports on the INTERNET,
send an e-mail message with "info" in the body to:
info@www.gao.gov
or visit GAO’s World Wide Web Home Page at:
http://www.gao.gov
PRINTED ON RECYCLED PAPER
United States Bulk Rate
General Accounting Office Postage & Fees Paid
Washington, D.C. 20548-0001 GAO
Permit No. G100
Official Business
Penalty for Private Use $300
Address Correction Requested